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Radius' (RDUS) Study on Tymlos for Osteoporosis in Men Meets Goal

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Radius Health, Inc. (RDUS - Free Report) announced positive top-line data from the phase III ATOM study which is evaluating its lead product, Tymlos (abaloparatide 80 mg subcutaneous [“SC”]) injection, for use in men with osteoporosis.

The primary endpoint of the study was to see the change in lumbar spine (“LS”) bone mineral density (“BMD”) compared to placebo at 12 weeks of treatment. The study met the primary endpoint by demonstrating statistical significance after 12 months.

Data from the study showed that participants who received Tymlos SC injection experienced an average increase in LS BMD of 8.5% versus an average increase of 1.2% in patients receiving placebo.

The study also met the secondary endpoints – the percentage change for LS BMD at six months, total hip BMD at 12 months and femoral neck BMD at 12 months versus placebo. The safety profile of Tymlos SC in the ATOM study was found similar to the data reported from previous studies.

The company plans to file a supplemental new drug application for Tymlos to treat men with osteoporosis in the first quarter of 2022.

Shares of Radius were up 5.7% on Monday following the announcement of the news. The stock has lost 10.6% so far this year compared with the industry’s decrease of 16.8%.

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We note that, presently, the Tymlos SC injection is approved in the United States for the treatment of postmenopausal women with osteoporosis at high risk of fracture defined as history of osteoporotic fracture — multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapies.

In the first six months of 2021, Tymlos generated sales worth $97 million, reflecting a decrease of 1% year over year. A potential label expansion of the drug should boost sales in the days ahead.

Radius is also developing an abaloparatide transdermal system for potential use in the treatment of postmenopausal women with osteoporosis.

Zacks Rank & Stocks to Consider

Radius currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the biotech sector include Fulcrum Therapeutics, Inc. (FULC - Free Report) , Athenex, Inc. (ATNX - Free Report) and Amicus Therapeutics, Inc. (FOLD - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Fulcrum Therapeutics’ loss per share estimates have narrowed 7.4% for 2021 and 10% for 2022, over the past 60 days. The stock has soared 96.8% year to date.

Athenex’s loss per share estimates have narrowed 9% for 2021 and 9.2% for 2022, over the past 60 days.

Amicus Therapeutics’ loss per share estimates have narrowed 1.3% for 2021 and 37.5% for 2022, over the past 60 days.